Mobile Video Education to Improve Patient Clinician Communication During Prenatal Clinic Visits

NCT06323343 | Completed Results

• 1 other identifier: 00040976
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this clinical trial is to test an animated video delivered by text message in patients whose pregnancies are complicated with fetal anomalies. The main question it aims to answer is: Does the video intervention prepare parents to talk to the doctors during prenatal appointments? Participants will be randomized to receive either the video intervention or links to the clinic's webpages. They will complete an enrollment survey before their appointment and a follow up survey after their appointment. The researchers will compare the video and webpage groups to see which group reports engaging in more of the identified best-practices of communication.

Conditions

Patient Empowerment

Keywords

Prenatal care; Congenital abnormalities; Communication; Mobile health

Outcome Measures

Primary Outcomes (1)

• Parents' Communication Behaviors Measure

  Participants' self-reported behaviors during the prenatal fetal anomaly appointment; of the 13 behavioral items, scored as percentage of behaviors reported, with higher scores indicating a higher rate of best-practice communication behaviors.

  Administered 1 day after appointment

Study Arms (2)

Video Intervention

EXPERIMENTAL

Participants assigned to the video intervention group receive a text message prior to their prenatal fetal anomaly appointment. Embedded in that text message is a link to an animated video which provides education on best practices of communicating with providers.

Other: Video Intervention

Webpage links

ACTIVE COMPARATOR

Participants assigned to the webpage links group receive links to the clinic's publicly available webpages prior to their prenatal fetal anomaly appointment. The webpages provide background about the providers and services available as well as a tour of the clinic.

Other: Webpage links

Interventions

Video Intervention OTHER

Animated video delivered by text message to prepare parents to communicate with physicians at their upcoming appointment for a fetal anomaly concern.

Video Intervention

Webpage links OTHER

Links to publicly available webpages about the fetal concerns clinic where the participants' appointments are scheduled.

Webpage links

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Pregnant patient scheduled for an appointment at the Children's Wisconsin Fetal Concerns Center for a fetal anomaly.
• Able to speak and understand English (intervention videos are only currently available in English).
• Age of 18 years or older.

You may not qualify if:

• Pregnant patient's appointment at Children's Wisconsin Fetal Concerns center is not for a fetal anomaly (e.g., screening only, past pregnancy with anomaly only cause of appointment)
• Pregnant patient is considering termination of pregnancy.

Sponsors & Collaborators

• Medical College of Wisconsin: lead

Study Sites (1)

Fetal Concerns Center Children's Wisconsin

Milwaukee, Wisconsin, 53226, United States

Location

MeSH Terms

Conditions

Patient Participation; Congenital Abnormalities; Communication

Condition Hierarchy (Ancestors)

Patient Acceptance of Health Care; Treatment Adherence and Compliance; Health Behavior; Behavior; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Limitations and Caveats

After five months of enrollment, an interim analysis was conducted by the principal investigator and study biostatisticians. Given the low likelihood of detecting a statistically significant difference with continued enrollment, the trial was stopped early for futility.

Results Point of Contact

• Title: Mir A Basir
• Organization: Medical College of Wisconsin

mbasir@mcw.edu

(414) 266-6820

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: March 14, 2024
• First Posted: March 21, 2024
• Study Start: June 15, 2024
• Primary Completion: December 11, 2024
• Study Completion: December 31, 2024
• Last Updated: March 24, 2026
• Results First Posted: March 24, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)